甘肃莫高实业发展股份有限公司制药厂复方甘草片年度质量回顾分析年度产品质量回顾分析报告产品名称:复方甘草片规格：100片/瓶×15瓶/盒×20盒/箱50片×300瓶/箱24片×2板/盒×10盒/收缩膜×30条/箱回顾日期：2011年07月01日－2012年07月30日起草：QA签名时间：审核：QA负责人签名时间：批准：质量受权人签名时间：甘肃莫高实业发展股份有限公司制药厂复方甘草片年度质量回顾分析[目录]1概要：........................................................................................................................12回顾期限....................................................................................................................13制造情况：................................................................................................................14产品描述：................................................................................................................14.1产品工艺..............................................................................................................14.2产品给药途径及适应症：..................................................................................84.3关键参数：..........................................................................................................95．物料质量回顾.............................................................................................................95.1原辅料、包装材料质量问题回顾....................................................................105.2主要原辅料购进情况回顾（附：原辅料的质量标准）................................105.3供应商的管理情况回顾....................................................................................115.4工艺用水、与药品直接接触的气体质量问题回顾........................................116.成品质量标准情况：.................................................................................................126.1产品质量标准....................................................................................................126.2质量指标统计及趋势分析................................................................................127.生产工艺分析：.........................................................................................................127.1关键工艺参数控制情况....................................................................................127.2中间体控制情况................................................................................................137.3工艺变更情况....................................................................................................137.4物料平衡（附表2）.........................................................................................137.5收率（附表2）.................................................................................................137.6返工与再加工....................................................................................................138偏差回顾：.................................................................................................................149超常超限回顾：.........................................................................................................1410产品稳定性考察：...........................................................................................1411拒绝批次：..................................................................................................
